Identity
- Trade Name
- Dako Omnis Large Vial, 30 mL EUDAMEDDako FDA UDI
- Generic Name
- Assay container IVD, single-use FDA UDI
- Device Name
- Dako Omnis Small Vial, 2 mL EUDAMEDDako Omnis Large Vial, 30 mL FDA UDI
- Model / Reference
- GC202 EUDAMEDFDA UDIGC20130-6 EUDAMED
- Description
- Dako Omnis Large Vial, 30 mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572034568 EUDAMEDFDA UDI
- Basic UDI-DI
- 570057P3007P3010A056601PR EUDAMED
- FDA Product Code
- KPA FDA UDI
- EMDN Code
- W0202059085 VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - CONSUMABLES EUDAMED
- GMDN Term
- Assay container IVD, single-use FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3800 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 30 Milliliter FDA UDI
Category: Assay container IVD, single-use
Dako by Agilent Technologies Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Agilent Technologies Inc.
Sources (2)
- FDA UDI 4b19e4e6-4637-431a-b8ba-e21ae35447a3 36 fields · synced Jul 21, 2026
- EUDAMED a49737dd-4fdd-41c6-9a1d-2658dadd19f5 61 fields · synced Jul 21, 2026